Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.

NCT01808885 | Completed Phase 1 DMC

• 3 other identifiers: WP298662012-005186-12TRO19622CLEQ1585-1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

safety; multiple sclerosis; olesoxime; double-blind; randomized

Outcome Measures

Primary Outcomes (1)

• Safety criteria

  Cumulative incidence of adverse events/serious adverse events (i.e. total number per patient) as assessed by ongoing monitoring.

  The primary endpoint of this study will be the cumulative incidence of AE/SAE assessed by ongoing monitoring at week 24 (day 168)

Secondary Outcomes (1)

• MRI Parameters

  Baseline (Visit 0), Week 12 (Visit 2) and Week 24 (Visit 3/Final Visit)

Other Outcomes (1)

• Exploratory MRI Parameters

  Baseline (Visit 0), Week 12 (Visit 2) and Week 24 (Visit 3/Final Visit)

Study Arms (2)

olesoxime (TRO19622)

EXPERIMENTAL

olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months. Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit).

Drug: olesoxime (TRO19622)

placebo

PLACEBO COMPARATOR

placebo (3 soft capsules, od) will be administered orally for 6 months

Drug: placebo

Interventions

olesoxime (TRO19622) DRUG

olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months. Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit).

Also known as: TRO19622 (olesoxime)

olesoxime (TRO19622)

placebo DRUG

placebo capsule shells with identical appearance as the active compound TRO19622

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 18 years old
• Diagnosed with Relapsing Remitting Multiple Sclerosis. Patients must be stable defined as free from relapsing episode for at least 6 months prior to Baseline
• Patients must be treated with Interferon beta for at least one year
• Patients must have an Expanded Disability Status Scale (EDSS) score ≤ 5
• Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception for at least 3 months prior to Baseline and during the study. In addition, female patients must not be lactating
• Patients must be able to understand and comply with study requirements
• Patients must provide a written, dated and signed informed consent prior to any study procedure

You may not qualify if:

• Any relapse of multiple sclerosis within the past 6 months prior to Screening Visit/Visit -1
• Any change in Interferon treatment within the past year prior to Screening Visit (Visit -1)
• Expected use of another disease modifying therapy from Screening Visit/Visit -1 to Visit 3/Final Visit
• Patients unable to undergo MRI scan
• Current or expected use of a medication that could interfere with olesoxime pharmacology (e.g. tamoxifen)
• Current or expected use of lipid lowering agents (ezetimibe, bile salt chelators, fibrates, phytosterols) other than statins
• Known hypersensitivity to olesoxime or any of its components
• History of alcohol or drug abuse within the last 6 months, or addiction within the last 2 years prior to Baseline Visit
• Positive urinary pregnancy test at Baseline Visit
• History of hepatitis B/C or HIV positive serology
• Hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\> 3 × ULN) at Baseline Visit
• History of renal impairment defined by a serum creatinine value \> 176 μmol/L (2.0 mg/dL) at Baseline Visit
• Abnormal and clinically significant ECG at Screening Visit/Visit -1 as assessed by a cardiologist
• Current or expected use of oral or intramuscular corticosteroids within 3 months prior to the Screening Visit. Only stable dose regimens of inhaled and topical corticosteroids are allowed during the study
• History of any clinically relevant gastrointestinal (GI), respiratory, psychiatric, neurological, kidney, liver, cardiac diseases, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives or put the patient's safety at risk, as judged by the Investigator

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Hôpital de la Timone: collaborator
• SGS S.A.: collaborator
• STRAGEN Services: collaborator

Study Sites (3)

Timone University Hospital, Neurology Department, UMR CRMBM CNRS 6612

Marseille, 13385, France

Location

CHU Reims, Maison Blanche Hospital, Neurology Department & University of Reims

Reims, 51092, France

Location

CHU Pontchaillou, Neurology Department

Rennes, 35033, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

olesoxime

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jean PELLETIER, MD

  Head of Neurology Department, UMR CRMBM CNRS 6612, Timone University Hospital, Marseille, France

  PRINCIPAL INVESTIGATOR

• Ayman TOURBAH, MD

  Professor of Neurology, Neurology Department & University of Reims

  PRINCIPAL INVESTIGATOR

• Gilles EDAN, MD

  Professor of Clinical Neurology, Head of Neurology Department, Pontchaillou Hospital, Rennes, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: March 11, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

FR (3)